Phase 4
N=300
Ketamine for Acute Pain Management After Trauma
Trauma Injury · Pain · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04129086 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day — 32; 39 MME per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine plus usual care (Drug); Usual Care (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day |
32; 39 | — |
| SECONDARY Pain as Assessed by Score on the Numeric Rating Scale (NRS) |
— | — |
| SECONDARY Number of Patients That Showed Signs of Delirium During In-hospital Stay |
16; 9 | — |
| SECONDARY Number of Patients That Required Unplanned Intubation During In-hospital Stay |
2; 3 | — |
| SECONDARY Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay |
7; 7 | — |
| SECONDARY Initiation of Ketamine Drip |
— | — |
| SECONDARY Duration of Ketamine Drip |
60; 76 | — |
| SECONDARY Number of Patients Requesting to Discontinue Ketamine |
9; 0 | — |
| SECONDARY Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch |
16; 20; 0; 0 | — |
| SECONDARY Ventilator Free Days |
30; 30 | — |
| SECONDARY ICU Free Days |
29; 28 | — |
| SECONDARY Hospital Free Days |
20; 21 | — |
| SECONDARY Number of Patients Discharged From the Hospital With an Opioid Prescription |
82; 97; 72; 81; 3; 2 | — |
| SECONDARY Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission |
78; 71 | — |
| SECONDARY Number of Patients Who Continue to Use Opioids at 6 Months Post Admission |
11; 11 | — |
| SECONDARY Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire |
30; 18; 35; 49; 36; 43 | — |
| SECONDARY Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) |
92; 94; 13; 25; 19; 10 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) |
50; 47; 15; 21; 12; 17 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) |
29; 38; 12; 10; 16; 14 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) |
29; 38; 12; 10; 16; 14 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) |
31; 25; 17; 21; 21; 24 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) |
50; 53; 15; 19; 11; 13 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) |
75; 80 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) |
69; 78 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) |
50; 47; 15; 21; 12; 17 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) |
29; 38; 12; 10; 16; 14 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) |
29; 38; 12; 10; 16; 14 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) |
31; 25; 17; 21; 21; 24 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) |
50; 53; 15; 19; 11; 13 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) |
75; 80 | — |
| SECONDARY Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) |
69; 78 | — |
| SECONDARY Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire |
30; 18; 35; 49; 36; 43 | — |
| SECONDARY Pain as Assessed by Score on the Behavioral Pain Scale (BPS) |
— | — |
| SECONDARY Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) |
2.9; 2.5 | — |
Summary
The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.
Eligibility Criteria
Inclusion Criteria
- Adult trauma patients
- Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)
- Randomization within 6 hours of arrival
Exclusion Criteria
- Patient not expected to survive
- Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac arrhythmia disorders (including atrial fibrillation), congestive heart failure, unstable coronary artery disease or recent myocardial infarction( MI)(within 6 months), cirrhosis, seizure disorder, and for those patients with unknown medical history - median sternotomy scar, mechanism of injury is fall from standing, 65 years of age or older, any arrhythmia on EKD)
- pregnancy
- in police custody
- history of dementia or movement disorder (i.e. Parkinson's)
Data sourced from ClinicalTrials.gov (NCT04129086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.